Bristol-Myers Squibb Holdings Ireland v Norton (Waterford) Ltd T/A Teva Pharmaceuticals Ireland

• Jurisdiction: Ireland
• Judge: Mr Justice Max Barrett
• Judgment Date: 17 February 2023
• Neutral Citation: [2023] IEHC 159
• Court: High Court
• Docket Number: [2021 No.4758 P]

Between

Bristol-Myers Squibb Holdings Ireland (‘BMS’)

Plaintiff

and

Norton (Waterford) Limited t/a Teva Pharmaceuticals Ireland (‘Teva’)

Defendant

[2023] IEHC 159

[2021 No.4758 P]

THE HIGH COURT

Interlocutory injunction – Supplemental protection certificate – Infringement – Plaintiff seeking an interlocutory injunction restraining the defendant from infringing a supplemental protection certificate – Whether the balance of convenience favoured the granting of the injunction sought by the plaintiff

Facts: The plaintiff, Bristol-Myers Squibb Holdings Ireland (BMS), by notice of motion of 2nd December 2022, applied to the High Court seeking an interlocutory injunction restraining the defendant, Norton (Waterford) Ltd t/a Teva Pharmaceuticals Ireland (Teva), from infringing Supplemental Protection Certificate No. 2011/032 (the SPC) and in particular by making, offering, putting on the market and/or using, and/or importing or stocking for the aforesaid purposes, a generic version of BMS’s medicinal products Eliquis (active ingredient: apixaban). The parties were agreed that in terms of the law to be brought to bear in deciding whether or not to grant the injunction the critical case in Irish law was the relatively recent decision of the Supreme Court in Merck Sharp & Dohme Corporation v Clonmel Healthcare Ltd [2019] IESC 65. O’Donnell J identified, at 36-37, the steps to be taken by a court in an interlocutory injunction such as that presenting.

Held by Barrett J that if BMS succeeded at trial a permanent injunction might be granted. He noted that it was not disputed that a fair question arose to be tried (and if it were disputed it was perfectly clear from the pleadings in the revocation application that there was a fair question arising to be tried). He undertook his analysis of the balance of convenience and the balance of justice. All in all, he considered that the balance of convenience favoured the granting of the injunction sought by BMS. Nine key factors stood out to him: (1) Teva intended to engage in intentional infringement of BMS’s SPC; (2) such infringement would cause loss to BMS that to some extent was not compensable in damages; (3) the SPC enjoyed a presumptive validity; (4) the ‘first mover advantage’ that Teva wished for was an advantage that would see it infringe BMS’s presumptively valid SPC; (5) BMS was not seeking to injunct Teva from doing anything that Teva had a prima facie legal right to do; (6) if Teva succeeded in the revocation proceedings, the calculation of Teva’s damages would be complex – however, calculating BMS’s damages would likewise be complex should BMS succeed; (7) insofar as he may have had regard to the likely outcome of the proceedings, there were strengths and weaknesses in the cases that both sides sought to make – but what BMS had was an SPC that was presumptively valid (so far as the ‘macro’ picture in the UK and the European Union was concerned, the two parties had essentially scored a ‘draw’ thus far in their various proceedings and no advantage derived therefore from considering same further); (8) he did not see that BMS’s procedural ‘misdemeanours’ in the conduct of the proceedings should render it ineligible, in all the circumstances presenting, for the interlocutory injunctive relief sought; (9) he did not see that the delay in the trial to next July had had an irremediable impact on the position of Teva. He held that there was effectively a draw when it came to the adequacy of damages, so the other factors considered above had an especial resonance in the application in terms of determining whether or not to grant the injunction sought. He noted that no breach of contract was claimed. He held that there would be an element of loss that would not be compensable in damages, so damages would not be a precise and perfect remedy for BMS. He did not see how it could be just not to grant the injunction sought in such circumstances – especially having regard to the other factors presenting.

Barrett J granted, on the terms sought, the injunction that BMS had come seeking.

Application granted.

JUDGMENT of Mr Justice Max Barrett delivered on 17 ^th February 2023 .

A. Introduction

1 . By notice of motion of 2nd December 2022, BMS has come seeking an interlocutory injunction restraining Teva from infringing the SPC and in particular by making, offering, putting on the market and/or using, and/or importing or stocking for the aforesaid purposes, a generic version of BMS's medicinal products Eliquis (active ingredient: apixaban). (Apixaban is, I understand, an anti-coagulant that is effective in the treatment of conditions that give rise to a risk of thromboembolism.)

B. Matters as Perceived by Parties

2 . A fulsome account of how the parties perceive matters to sit between them at this time is outlined in the affidavit of Mr O'Brien, as sworn on 2nd December 2022, the affidavit of Ms Reynolds, as sworn on 20th December 2022, and the further affidavit of Mr O'Brien, as sworn on 16th January 2023, extracts from each of which I quote below.

3 . Mr O'Brien avers, amongst other matters, as follows:

“ 5. The proceedings are patent/SPC infringement proceedings that were taken, initially on a quia timet basis, in circumstances where Teva had applied for a marketing authorisation for an infringing generic apixaban, indicated that it intended to ‘clear the path’ of the relevant rights by taking an invalidity action seeking revocation of the relevant patent and SPC and that it intended to launch its generic product by mid 2022 and refused to give any undertaking not to launch….

6. The SPC extends the exclusive rights BMS enjoys under European Patent (IE) 1 427 415 entitled ‘Lactam-containing compounds and derivatives thereof as factor Xa inhibitors’ (the ‘Patent’) in respect of apixaban and pharmaceutically acceptable salts thereof. The Patent expired on 17 September 2022 and the SPC is due to expire on 19 May 2026, though that date may be extended by a possible paediatric extension.

7. BMS seeks an interlocutory injunction in circumstances where: (a) Teva accepts that the product that it proposes to launch in the State infringes the SPC and the Patent before it expired (in related invalidity proceedings…(the ‘Revocation Action’). Teva asserts that the Patent and consequently the SPC, was invalid); (b) launch of Teva's product would cause irreparable damage to BMS…(c) an order restraining launch of Teva's product pending trial, if reversed on determination of substantive case however, would merely cause a delay to Teva's plans which would be more readily compensable in damages than the loss that BMS would suffer in the event of an unlawful launch.

8. It is clear from the terms of Teva's notice of its intention to launch that Teva places its hope of resisting interlocutory relief in the accusation that it has been thwarted in its attempts to prosecute the Revocation Action and ‘clear the path’ of the SPC by BMS such that the balance of convenience favours the denial of the relief sought….

9. There are two fundamental problems with Teva's narrative in this regard.

10. First, it presupposes that Teva will be successful in the Revocation Action in circumstances where I respectfully believe the indications are to the contrary and where BMS is confident in its right in and to the SPC and in its defence of it in the Revocation Action.

11. Second, the fact that the Revocation Action has not been completed in advance of Teva's desired launch date is a matter that is entirely down to Teva. As I outline in more detail below:

• (a) Teva chose, apparently arbitrarily, a proposed launch date for its product – the date initially flagged in its pre-action correspondence was mid-2022 – this has clearly shifted since that initial indication, but crucially neither mid-2022 nor any time before the trial of this action in June 2023 is a significant date in terms of imminent expiry of the right, or any other matter that would make time of the essence.

• (b) Teva then appeared to decree the amount of time that it would allow this Honourable Court to hear and determine the Revocation Action. Working back from mid-2022, by initiating the action in March of 2021, Teva allowed one year and a quarter – by any reckoning, a very tight timeline for the determination of a complex invalidity action.

• (c) Significantly and from the inception of the dispute in the State, Teva clearly never conceived of its launch proposals as being contingent on the Court's determination of the validity of the Patent/SPC. On the contrary it consistently privileged its commercial plans over the Court's determination of the issues and repeatedly refused to give any undertaking not to launch before the hearing and determination of the matter – even on its own extremely ambitious timeline.

• (d) Within an already extremely constrained timeline, and 8 months into the action, Teva decided to double the size and complexity of the trial by amending its proceedings to seek the invalidation of the Patent (and consequently the SPC) on an entirely separate, non-technical patent ground, i.e., on the basis that the BMS company that applied for the Patent on which the SPC is based was not the BMS company that was entitled to claim an earlier priority date for it; this has implications for validity because the later priority date affects the prior art available to challenge the novelty of the Patent and Teva asserts the publication of one of BMS's own patents between the priority date and the filing date of the Patent in this regard.

• (e) Teva then proceeded to seek to telescope the time for discovery and witness statements regarding this entirely new case and demand exacting attention to them.

• (f) Teva then raised extensive interrogatories – most of which were irrelevant and/or unnecessary and/or resulted from Teva's refusal to engage with normal accommodations on...